跳至主要内容
临床试验/NCT07342907
NCT07342907招募中不适用

Effectiveness of Internal Family Systems Therapy in Improving Mental Health in Individuals With Borderline Personality Disorder

Waypoint Centre for Mental Health Care1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
1
主要终点
Severity of borderline personality disorder symptomatology - disorder-specific mental distress

研究概览

简要总结

Borderline Personality Disorder (BPD) involves intense emotional ups and downs, unstable relationships, impulsivity, and a poor sense of self. These challenges often lead to addiction, self-harm, and frequent use of healthcare services. While certain treatments already in practice - such as dialectical behavior therapy - can help, they don't work for everyone or address all aspects of the disorder. This study plans to explore internal family systems (IFS) therapy, a method that views the mind as made up of different "parts" - each with its own thoughts and feelings. IFS helps people build understanding and compassion toward these parts and connect with a calmer, more centered "Self." This may be especially useful for those with BPD, who often feel fragmented and extremely critical of themselves and others. This will be the first study to examine internal family systems therapy for BPD. The participants (15 in total) will receive up to 50 individual sessions over 15 months. Changes in symptoms and overall mental health will be measured at four points during the study. People with lived experience of BPD will help shape the research to ensure it is relevant, respectful, and useful for others facing similar challenges.

详细描述

Brief background and rationale: Borderline personality disorder (BPD) is a chronic and disabling psychiatric condition marked by pervasive affective instability, identity disturbance, interpersonal dysfunction, and impulsivity. It affects approximately 1-2% of the general population and up to 20% of psychiatric populations, contributing substantially to healthcare utilization, suicide risk, and long-term disability. Existing evidence-based psychotherapies for this condition, such as dialectical behavior therapy, mentalization-based therapy, or schema therapy show significant benefits but these are modest and these interventions are quite resource-intensive. There remains a need for additional, theoretically grounded treatments that target core pathomechanisms of BPD-particularly emotion dysregulation, shame, and self-fragmentation.

Objectives: The primary objective of this pilot study is to assess preliminary effectiveness of internal family systems (IFS) therapy in reducing BPD symptom severity from baseline to post-treatment. Secondary objectives are to evaluate changes in emotion dysregulation, shame, self-compassion, interpersonal functioning, depression, anxiety, addictive behaviors and overall well-being; as well as to assess feasibility (recruitment, retention, adherence), acceptability, and safety. It is hypothesized that participants will demonstrate at least small-to-moderate improvements in BPD symptom severity, with congruent changes across secondary outcomes. Although clinical interest in IFS has grown exponentially in the past decades, empirical evaluation remains limited, and no studies to date have specifically examined its use in any personality disorder. Given the strong theoretical fit between IFS principles and BPD phenomenology, a structured pilot investigation is warranted to establish feasibility, safety, and preliminary effectiveness prior to larger controlled trials.

Study design: The study will use a single-group, repeated-measures design with assessments at baseline, 4 months, 8 months, and post-intervention (12-15 months). A target sample of fifteen adults will be recruited. Inclusion criteria are age 18 or older, sufficient English proficiency for participation, and a formal BPD diagnosis confirmed by a referring clinician. Exclusion criteria include active psychosis or mania, cognitive impairment, inadequate English comprehension, or participation in another form of psychotherapy during the study period.

Intervention: Internal family systems therapy, developed by Richard Schwartz, is an integrative psychotherapy that conceptualizes the mind as a system of subpersonalities ('parts') organized around a compassionate, stable core Self. The approach promotes internal harmony through increasing awareness, acceptance, and cooperation among these parts and the Self. Participants will receive weekly, one-hour IFS therapy sessions in the private mental health care setting over approximately 12 to 15 months. Treatment will be delivered by two licensed mental health professionals trained in the IFS model. Participants will pay a significantly subsidized session fee to reduce financial burden of participation in the intervention.

Outcomes: The primary outcome is BPD symptom severity measured by the Borderline Symptom List-23 and its supplement. Secondary outcomes include validated measures of emotion dysregulation (DERS-18), shame and guilt (GSQ-8), self-compassion (SCS-SF), interpersonal functioning (EXIS.pers), depression (PHQ-9), anxiety (GAD-7), addictive behaviors (SSBA-G), and well-being (WHO-5). Feasibility and acceptability will be evaluated through attendance, retention, and brief structured questionnaires.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Resident of Ontario, Canada;
  • Sufficient fluency in English to provide informed consent, participate in therapy sessions, and complete self-reported assessments;
  • Diagnosis of borderline personality disorder confirmed by a healthcare professional authorized to establish such a diagnosis in Ontario;
  • Willingness and ability (including financial means) to participate in the 50-session, 12-15-month intervention and the study assessments;
  • Capacity and willingness to provide written informed consent.

排除标准

  • Current manic or psychotic symptoms regardless of diagnosis;
  • Substance dependence severe enough to interfere with meaningful level of engagement in the study intervention.
  • Cognitive impairment or neurological disorders that would preclude informed consent or meaningful participation in the study intervention.
  • Concurrent participation in any another form of psychotherapy.

研究组 & 干预措施

Intervention recipients

Experimental

Participants will engage in internal family systems therapy in the individual format. This form of psychotherapy conceptualizes the mind as a system of subpersonalities ('parts') organized around a compassionate, stable core Self. The approach promotes internal harmony through increasing awareness, acceptance, and cooperation among these parts and the Self. Participants will receive weekly, up to 50, one-hour IFS therapy sessions in the private mental health care setting over approximately 12 to 15 months. Treatment will be delivered by two licensed mental health professionals trained in the IFS model. Participants will pay a significantly subsidized session fee to reduce financial burden of participation in the intervention.

干预措施: Internal family systems therapy (Behavioral)

结局指标

主要结局

Severity of borderline personality disorder symptomatology - disorder-specific mental distress

时间窗: Change in scores between baseline and intervention end (approx. 12-15 months)

This first indicator of the primary outcome will be assessed by the Borderline Symptom List (BSL-23, Bohus et al., 2009). This self-report measure consists of items that 1) are based on DSM diagnostic criteria as well as expert opinions and expert-by-experience input; and 2) displayed a high level of sensitivity to change and ability to discriminate individuals with versus without borderline personality disorder. Scale items cover areas such as affective instability, emotional pain, identity disturbance, interpersonal sensitivity, cognitive-perceptual distress, impulsivity-related subjective distress, and suicidal ideation. Total scores range from 0 to 92 with higher scores indicating greater severity of borderline personality disorder symptoms.

Severity of borderline personality disorder symptomatology - dysfunctional behaviors

时间窗: Change in scores between baseline and intervention end (approx. 12-15 months)

This second indicator of the primary outcome will be assessed by the supplementary scale of the Borderline Symptom List (BSL). This 11-item scale (BSL-Supplement; Bohus et al., 2007) assesses the extent of dysfunctional behaviours associated with borderline personality disorder such as self-injurious behaviour, suicidality, binge and purge behaviours, impulsivity, hostile outbursts, and sexual promiscuity. Total scores range from 0 to 44 with higher scores reflecting greater frequency or severity of borderline-related behaviors.

次要结局

  • Emotion dysregulation(Change in scores between baseline and intervention end (approx. 12-15 months))
  • Addictive behaviors(Change in scores between baseline and intervention end (approx. 12-15 months))
  • Interpersonal functioning(Change in scores between baseline and intervention end (approx. 12-15 months))
  • Shame and guilt(Change in scores between baseline and intervention end (approx. 12-15 months))
  • Self-compassion(Change in scores between baseline and intervention end (approx. 12-15 months))
  • Anxiety(Change in scores between baseline and intervention end (approx. 12-15 months))
  • Depression(Change in scores between baseline and intervention end (approx. 12-15 months))
  • General psychological well-being(Change in scores between baseline and intervention end (approx. 12-15 months))

研究者

发起方
Waypoint Centre for Mental Health Care
申办方类型
Other
责任方
Principal Investigator
主要研究者

Barna Konkoly-Thege

Research Psychologist

Waypoint Centre for Mental Health Care

研究点 (1)

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